May 23, 2023 – The maker of the blockbuster drugs Ozempic and Wegovy says a pill version achieves similar weight loss results and will be up for FDA approval later this year.
Danish drugmaker Novo Nordisk announced the phase III trial results Tuesday for the pill, which contains the same active ingredient as the popular injection versions.
“The choice between a daily tablet or weekly injection for obesity has the potential to offer patients and health care providers the opportunity to choose what best suits individual treatment preferences,” said Martin Holst Lange, MD, PhD, executive vice president for development at Novo Nordisk, in a statement.
In a trial of 667 people who were overweight or obese, those who took the daily semaglutide pill lost 17% of their body weight after 68 weeks. People who took a placebo pill lost 1.8% of their body weight during the same time period. The average starting weight of a person in the study was 232 pounds, which means the typical participant lost about 40 pounds during the nearly 6-year study.
The company said the semaglutide pill “appeared to have a safe and well-tolerated profile,” and the most common side effects were gastrointestinal in nature that “were mild to moderate and diminished over time.”
The side effects were comparable to those experienced by people taking Ozempic or Wegovy.
Ozempic is FDA-approved for people with type 2 diabetes, and Wegovy is approved for weight management. Both of the weekly shots contain the drug semaglutide, but in differing dosages. The new pill form is intended for weight management.
Both Wegovy and Ozempic have experienced supply shortages in the U.S. amid growing demand. Novo Nordisk said it will apply for FDA approval by the end of this year for the new pill version. The company declined to comment when asked about manufacturing capacity, Reuters reported, also noting that Pfizer is developing a similar oral semaglutide treatment for diabetes.
Semaglutide mimics a gut hormone called glucagon-like peptide-1 (GLP-1), which helps the brain regulate appetite and can also influence food cravings. Novo Nordisk already makes a semaglutide pill that is FDA-approved for people with diabetes. Called Rybelsus, the pill must be taken according to strict criteria and showed limited weight loss in trials.